Validation of a Virtual Reality Test for the Assessment of Visually Impaired Patients Undergoing Low Vision Rehabilitation

NCT07092124 | Recruiting

• 1 other identifier: P_VST_2025_2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Low vision rehabilitation is a vital part of care for visually impaired patients, who are usually referred to orthoptists to develop visual strategies and optimize residual vision. This rehabilitation significantly improves quality of life by enhancing autonomy and reducing depression. It employs various tools, from traditional exercises to specialized software. Advances in virtual reality (VR) offer new promising opportunities by creating immersive environments tailored to patients' residual vision, increasing motivation and exercise effectiveness. In this context, VisionumVR was developed-a VR test using the Meta Quest 3 headset to assess functional vision during rehabilitation. It evaluates hand-eye coordination, visual discrimination, and visual exploration through a daily-life-inspired task. This standardized 20-minute test aims to measure patients' progress throughout their orthoptic rehabilitation.

Conditions

Low Vision

Outcome Measures

Primary Outcomes (1)

• repetability

  Repeatability coefficient of performance on the VisionumVR test

  Day 0 and Month 1

Study Arms (1)

Test visionumVR

EXPERIMENTAL

Device: test visionumVR

Interventions

test visionumVR DEVICE

Two evaluation sessions with VisionumVR one month apart

Test visionumVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient (regardless of visual pathology) who is about to begin or has begun orthoptic low vision rehabilitation;
• Patient requiring at least five orthoptic rehabilitation sessions that can be completed before the end of the study;
• Binocular visual acuity ≥ 1/20 (≤ 1.3 logMAR), regardless of type of vision loss (central, mixed, or peripheral);
• Sufficient knowledge of the French language.

You may not qualify if:

• Neurodegenerative diseases or any other condition that could interfere with the planned assessments in this study (known epilepsy and/or history of seizures, dysfunction of the dominant upper limb, etc.);
• Medications that may cause motor, visual, or cognitive impairments (neuroleptics, etc.) or interfere with the study assessments;
• Pregnant women (pregnancy can cause vision fluctuations, and wearing a virtual reality headset is not recommended);
• Participation in another clinical trial that may interfere with the current study;
• Inability to follow instructions or read.

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead
• Streetlab: collaborator

Study Sites (2)

Centre Régional Basse Vision et Trouble de l'Audition

Angers, 49100, France

RECRUITING

Institut de Réadaptation Visuelle Saint-Louis

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Amelie Yavchitz, Dr

CONTACT

+33148036454; ayavchitz@for.paris

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 29, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

FR (2)